Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

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Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose.

Frequency of Relapses in Patients Treated for up to 24 Months [ Time Frame: 24 months ]

Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).

Secondary Outcome Measures :

New/Newly Enlarged T2 Lesions [ Time Frame: 24 months ]

Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24

Time to First Relapse [ Time Frame: 24 months ]

Time to first relapse was determined.

Proportion of Patients Relapse-free [ Time Frame: 24 months ]

Proportion of patients relapse-free was determined

T1 Gd- Enhancing Lesions [ Time Frame: 24 months ]

Number of T1 Gd-enhancing lesions per scan up to Month 24

Pharmacokinetics (Cavg) of Fingolimod-P [ Time Frame: 24 months ]

Cavg (average drug concentration over the dose interval) will be evaluated.

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Ages Eligible for Study:

10 Years to 17 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Key Inclusion Criteria:

diagnosis of multiple sclerosis

at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive

Key Exclusion Criteria:

patients with progressive MS

patients with an active, chronic disease of the immune system other than MS

patients meeting the definition of ADEM

patients with severe cardiac disease or significant findings on the screening ECG.

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com